Some advocates argue for lowering FDA standards for medical device approval in order to hasten American’s access to superior treatment. They say it takes longer in the U.S. to bring new technology to market than it does in Europe, and our care can be inferior as a result.
Sometimes this blog objects to how the FDA works (See “FDA Workers Say Outsiders Influence Medical Device Decisions” and “Are Medical Device Industry Dollars Funding Lax Oversight?”), but the “first to market” push is a bogus race.
Results of research recently published in the New England Journal of Medicine (NEJM) quantifies this nonsense. Its data show that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the United States as it does in the four largest European markets--Germany, France, Italy and Britain. The reason is because in those countries, access generally is delayed until decisions are made about how medical providers get reimbursed for using the new stuff. That process often takes substantially longer in Europe than in the United States.
The researchers looked at three comparative factors--how innovative was the device; how long it took from the submission of the application to its appearance on the market; and how many patients got access to it as defined by the time it took for the reimbursement decision.
Innovation was deemed important because the FDA requires the strongest evidence of clinical benefit for new medical devices, and such products inspire the most debate about the relative effectiveness of approval processes elsewhere. Previous studies have shown that lower-risk (less innovative) devices reach the market at about the same rate in the U.S. and Europe.
Measuring the time it takes from when the approval application is made to when a device is accessible on the market is important because previous studies compared dates of application and market access by chronology, but application dates vary among countries, so there’s no single start point.
Determining patient access to a device according to when the reimbursement decision is made instead of when it’s approved is important because access to a new device doesn’t happen on a broad scale until a third-party payer forks over the price of using it. Previous U.S.-vs.-Europe studies used the approval date to mark the time of product availability, but innovative, high-risk devices don’t reach the market that soon. Only patients who can afford to pay out of pocket benefit immediately on approval. Insurers take longer to decide whether to approve the treatment, and at what cost. Public underwriters generally take longer than private insurers to make reimbursement decisions. Significantly more Europeans than Americans have public insurance.
Last year, the FDA approved 40 applications for pre-market approval (PMA is the most stringent approval process). The average review time was 13.1 months; of that, it took the FDA 8.4 months to review the application and the applicant took 4.7 months to address deficiencies in the application (called “sponsor time”). Some devices require more extensive review if they have limited or conflicting evidence of clinical benefit. Those cases averaged 8.6 months over the last five fiscal years
It’s difficult to obtain data on how long private insurers take to make coverage decisions, but anecdotal information from private insurers indicates it takes a few weeks to a few months after FDA approval, depending on the amount and quality of evidence of clinical benefit.
Most of the 27 member countries of the European Union have publicly financed health-care systems, which cover approximately 8 in 10 people in the four largest device markets. The process to obtain approval throughout the EU is conducted by for-profit, third-party agencies accredited by a member country to assess device safety and performance. The agencies, however, do not evaluate effectiveness, which requires more clinical data. It is estimated that this process takes 1 to 3 months, excluding sponsor time.
But most European patients do not have access to innovative, high-risk devices as soon as they are approved by the whole EU—each country decides reimbursement policy separately. Even though the whole EU can grant device approval based on fewer clinical data than are required for FDA approval, European standards for reimbursement are often similar to or higher than those the FDA imposes for device approval. European countries might require additional data on safety and effectiveness, as well as on cost-effectiveness.
Among the four main countries, the time for reimbursement decisions varies: Germany averages 71.3 month, France ranges from 36 to 48 months, Italy ranges from 16.4 to 26.3 months and Britain averages 18 months.
The NEJM researchers concluded that the public reimbursement decision process in the U.S. (Medicare, Medicaid, etc.) takes about as long as it does in Italy and Britain, about half as long as France and less than one-third as long as Germany. The difference is even greater when it comes to private insurers.
The point, say the researchers, is that one cannot make sweeping generalizations about the efficacy of bringing new medical devices to market unless one examines how soon the most people gain the benefit of the new device.
There’s enough political and commercial noise about how good or inept is the FDA when it comes to medical device review and approval without complicating the issue with misleading statistical comparisons and sweeping, perfect-world pronouncements. Medical devices have the power to heal or harm, and the faster-is-better philosophy not only isn’t true in national comparisons, it isn’t good health policy.